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Coding, Reimbursement, and Patient Support Information

Effective January 1, 2015, Injectafer® (ferric carboxymaltose injection) has a unique
product-specific J-Code: J1439.
This code may only be used for Injectafer® administered on or after January 1, 2015.
J-Codes have universal acceptance and are recognized by all payers.

American Regent, Inc. has created a toll-free hotline to help physicians and other providers understand payers’
coverage and reimbursement policies for Injectafer®, and when necessary, address reimbursement issues.
This service can be reached at 877-4-IV-IRON, Monday through Friday, between 9:00 AM and 8:00 PM, Eastern-time.

Specifically, hotline Reimbursement Specialists can assist with the following:

Support providers in appealing denied claims or inadequate reimbursement for Injectafer® and Venofer®.
The hotline helps track claims for administration services, including regular follow-up with payers to
facilitate reimbursement. If a claim is denied, our program staff is available to coordinate the appeals
process through the development of letters of medical necessity and coverage appeal request letters.

Patient Assistance Program

A program for patients who lack insurance coverage.

American Regent, Inc. created the IV Iron Patient Assistance Program to improve access to
Injectafer® (ferric carboxymaltose injection) and Venofer® (iron sucrose injection, USP) for
patients who lack health insurance and cannot afford therapy. If a patient is eligible, American Regent,
Inc. will replace the Injectafer® or Venofer® provided free-of-charge while the patient is
enrolled in the program.

PROGRAM ELIGIBILITY

To be eligible for the program, patients must completely lack health insurance and be ineligible for public
insurance or financing. The patient must also be a US citizen, legal entrant in the United States, or permanent
resident. Proof of citizenship or legal residency may also be required. Patients must also meet income and other
criteria as established by American Regent, Inc. American Regent, Inc. reserves the right to modify or cancel the
program immediately with respect to any patient, or in its entirety, at any time.

HOW TO APPLY

Providers (hospitals, physicians, or infusion centers) may apply to the Program on behalf of their patients.
Please download an Enrollment Application and Product Replacement Request forms below.

For American Regent’s Customer Service or Medical Affairs departments, please call 1-800-645-1706.

IMPORTANT SAFETY INFORMATION

INDICATIONS/CONTRAINDICATIONS

Injectafer® (ferric carboxymaltose injection) is an iron replacement product indicated for the
treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have had
unsatisfactory response to oral iron, and in adult patients with non-dialysis dependent chronic kidney
disease. Injectafer® is contraindicated in patients with hypersensitivity to
Injectafer® or any of its inactive components.

WARNINGS AND PRECAUTIONS

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been
life-threatening and fatal, have been reported in patients receiving Injectafer®. Patients may present with shock,
clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms
of hypersensitivity during and after Injectafer® administration for at least 30 minutes and until clinically stable
following completion of the infusion. Only administer Injectafer® when personnel and therapies are immediately
available for the treatment of serious hypersensitivity reactions.
In clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of
subjects receiving Injectafer®. Other serious or severe adverse reactions potentially associated with
hypersensitivity which included, but were not limited to, pruritus, rash, urticaria, wheezing, or hypotension
were reported in 1.5% (26/1775) of these subjects.

In clinical studies, hypertension was reported in 3.8% (67/1775) of subjects. Transient elevations in systolic
blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1775) of
subjects. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor
patients for signs and symptoms of hypertension following each Injectafer® administration.

In the 24 hours following administration of Injectafer®, laboratory assays may overestimate serum iron and transferrin
bound iron by also measuring the iron in Injectafer®.

ADVERSE REACTIONS

In two randomized clinical studies, a total of 1775 patients were exposed to Injectafer®, 15 mg/kg of body weight,
up to a single maximum dose of 750 mg of iron on two occasions, separated by at least 7 days, up to a cumulative dose
of 1500 mg of iron. Adverse reactions reported by ≥2% of Injectafer®-treated patients were nausea (7.2%); hypertension (3.8%);
flushing/hot flush (3.6%); blood phosphorus decrease (2.1%); and dizziness (2.0%).

The following serious adverse reactions have been most commonly reported from the post-marketing spontaneous reports:
urticaria, dyspnea, pruritus, tachycardia, erythema, pyrexia, chest discomfort, chills, angioedema, back pain, arthralgia,
and syncope.

American Regent® is a registered trademark of
Luitpold Pharmaceuticals, Inc.
Injectafer® and the Injectafer® logo are trademarks
of Vifor (International), Inc., Switzerland. Injectafer® is manufactured under license from Vifor (International), Inc.,
Switzerland. @ 2015 American Regent, Inc.